EU regulator revises guidelines for Alzheimer's, Parkinson's

Regulators in Europe have issued what they describe as “substantially revised versions” of guidelines for companies developing medicines for the treatment of Alzheimer's disease and other dementias, plus Parkinson's disease.

The European Medicines Agency says it is making the move “in the light of recent scientific progress in the understanding of these diseases and conditions”. It adds that “advances in clinical science, physiopathology and molecular biology have stimulated new interest in the development of more effective symptomatic or disease-modifying treatments”.

The guidelines were developed in response to the need of companies developing these new types of medicines for guidance on appropriate clinical-trial designs, the EMEA states. The agency adds that as life expectancy increases, “neurodegenerative diseases and dementia will affect more and more people over the coming decades”, and these guidelines, which come into effect on February 1 next year, are expected to help improve the availability of drugs to treat such diseases and conditions.

The guidelines are prepared by the EMEA's Committee for Medicinal Products for Human Use and its relevant working parties, “in consultation with the agency's stakeholders”. They reflect “an approach to specific scientific issues that is harmonised across the European Union” but the EMEA noted that “the recommendations they contain are not binding, and sponsors may deviate from them, provided they can substantiate their approach”.